Stent thrombosis occurred in 11 of 312 STEMI patients who received distal protection (DP) compared to 4 of 314 patients treated conventionally, according to the 15 month results of DEDICATION (Drug Elution and Distal Protection in ST Elevation Myocardial Infarction Trial) published in JACC. The study also found more target lesion revascularizations (31 vs 18) and target vessel revascularizations (37 vs 22) in the group randomized to receive distal protection.
The Danish investigators concluded:
The present randomized study found no benefit with respect to short-, intermediate-, or long-term angiographic or clinical end points. On the contrary, we found a significantly increased rate of adverse cardiac events within 15 months in the group of patients treated with routine DP. Together with the results of previous studies evaluating DP, the results of the DEDICATION trial demonstrate that routine use of a filter wire in its present form cannot be advocated and probably should be avoided with primary PCI for STEMI.
Peter Berger of Geisinger Clinic told CardioBrief that there have now been 12 trials of DP in STEMI patients and that all the trials have failed to uncover any evidence of benefit for the devices when used for this indication. As a result, he said, DP is used in only a very small minority of STEMI cases. Berger said it was possible that the evidence of harm in DEDICATION was bad luck or just the play of chance, but “there’s clearly no benefit so these devices should not be routinely used in this population.”
In vein grafts, however, Berger noted that these devices are “very well studied” and have been shown to reduce “big consequential MIs.” Commented Berger: “I’m less concerned that a very small percentage of MI patients may still be being treated with embolic protection devices then I am that 50-60% of patients undergoing vein graft PCI don’t receive embolic protection.”